SPINAL USA CEMENT RESTRICTOR SYSTEM

Prosthesis, Hip, Cement Restrictor

SPINAL USA

The following data is part of a premarket notification filed by Spinal Usa with the FDA for Spinal Usa Cement Restrictor System.

Pre-market Notification Details

Device IDK060132
510k NumberK060132
Device Name:SPINAL USA CEMENT RESTRICTOR SYSTEM
ClassificationProsthesis, Hip, Cement Restrictor
Applicant SPINAL USA 213 EASTSIDE LANE Brandon,  MS  39047
ContactJeffrey Johnson
CorrespondentJeffrey Johnson
SPINAL USA 213 EASTSIDE LANE Brandon,  MS  39047
Product CodeJDK  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-01-18
Decision Date2006-03-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840019929271 K060132 000
00840019908849 K060132 000
00840019908832 K060132 000
00840019908825 K060132 000
00840019908818 K060132 000
00840019908801 K060132 000
00840019908795 K060132 000
00840019908788 K060132 000
00840019908771 K060132 000
00840019908764 K060132 000
00840019908856 K060132 000
00840019908863 K060132 000
00840019929264 K060132 000
00840019929240 K060132 000
00840019929257 K060132 000
00840019929233 K060132 000
00815362022122 K060132 000
00840019908900 K060132 000
00840019908894 K060132 000
00840019908887 K060132 000
00840019908870 K060132 000
00840019908757 K060132 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.